comparison of two closed-loop strategies for glucose control in type 1 diabetes the dremed trail- 2

Conditions: Type 1 Diabetes

Summary: the purpose of the study is to compare two closed-loop strategies in terms of glycemic control in type 1 diabetes during a camp setting. the proposed study is a four-segment feasibility study. one segment is a proof of concept study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms, cross-over, randomized and single-center and the third segment is four-arms, parallel, randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home. segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control. part 2-is a randomized cross-over (two arms) in-patient study: a total of 12 patients will participate in this part of the study. following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 36 hours in hospital setting. during the first period, glycemic control will be controlled by the hybrid closed-loop system and during the second period by hybrid logic closed-loop system. the sequence of treatment first period hcl therapy than ahcl or vice versa will be randomly assigned. segment 2 is a randomized cross-over (two arms) camp study including up to 30 patients. following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment, each period will last 2days in a camp setting, the total duration of the camp will be up to 6 days. in one period, glycemic control will be controlled by the hybrid closed-loop system and another period by hybrid logic closed-loop system. the sequence of treatment first period hcl therapy than ahcl or vice versa will be randomly assigned. segment 3 is a randomized, parallel (four arm) camp study including up to 80 patients. following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings. the duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system: hybrid closed loop (hcl) or one of 3 versions of advanced hybrid closed loop (ahcl). segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three week period at home. after the completion of segments 1-3, the ahcl system will be optimized and a new version of the system will be created for use in segment 4. up to 20 subjects will participate in this part of the study. following a minimum of 5 days run-in period, subjects will be placed in a camp setting and closed loop will be initiated. subjects will remain in closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late meal bolus and moderate-intensity exercise. at the conclusion of the camp, subjects will continue to use the system at home in auto mode for a period of 21 days.


Eligibility criteria:
inclusion criteria: * diabetes duration \> 1 year since diagnosis * pump therapy for at least 6 months and experience with sensor use * age10-40 years: age 10-30 for segments 1-3, age 14-40 for segment 4. * 7\>hba1c \<10.0 at time of screening visit for segments 1 and 2, \<10.0 at segments 3 and 4. * willing to follow study instructions * willing to perform ≥ 3 finger stick blood glucose measurements daily * willing to perform required sensor calibrations * patient capable of reading and understand instructions in english * willing to have an adult experienced in the management of diabetes to live with during the outpatient phase of the protocol. exclusion criteria: * subject is unable to tolerate tape adhesive in the area of sensor placement * subject has any unresolved adverse skin condition in the area of sensor or device placement * subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks * subject has a positive pregnancy screening test * subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception * subject has had a hypoglycemic seizure within the past 6 months prior to screening visit * subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit * subject has had an episode of diabetic ketoacidosis (dka) within the past 6 months prior to screening visit * subject has a history of a seizure disorder * subject has central nervous system or cardiac disorder resulting in syncope * subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (tia), cerebrovascular accident (cva), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease * subjects with hematocrit lower than the normal reference range per local lab testing * subjects with a history or findings on screening electrocardiogram of any cardiac arrhythmia * subjects with a history of adrenal insufficiency * subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment * any disease or condition that may influence the hba1c testing * subject needs to travel by air during the study duration.

Keywords: closed loop artificial pancreas